跳至主要内容
临床试验/NCT02985008
NCT02985008Unknown不适用

SMart Angioplasty Research Team: A Multi-center, Open, REtrospective and Prospective Observational Study to Investigate Clinical oUtcomes and Efficacy of Left Ventricular Assist Device for Korean Patients With Cardiogenic Shock : RESCUE

Jeong Hoon Yang1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,000
试验地点
1
主要终点
In hospital death

研究概览

简要总结

Retrospectively and prospectively enrolled patients with cardiogenic shock in domestic manifolds and investigated the current state of treatment and clinical features of cardiogenic shock in Koreans and identified the factors that could improve the prognosis and the use of IABP and ECMO And to investigate its therapeutic effect.

详细描述

  1. The selection / exclusion criteria for persons with cardiogenic shock should be verified by medical records from January 1, 2014 before the approval date of each institution's clinical trial screening committee.
  2. If a cardiogenic shock to the selection criteria is found in the emergency room, general ward, or intensive care unit of the participating institutions, enroll in this study and fill in the information according to the e-CRF.
  3. After 1, 6 and 12 months, visit the hospital for examination and procedures. The person in charge of the examination or the delegate of the examiner may follow the person by telephone or an outpatient visit.

研究设计

研究类型
Observational
观察模型
Cohort

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 19 years old or older
  • ① Systolic blood pressure is less than 90mmHg for more than 30 minutes despite the fluid therapy, or Use of pressure boosting agents is necessary.
  • ② Peripheral hypopnea (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol / l) or a person with pulmonary edema.
  • Causes of cardiogenic shock include acute myocardial infarction (including in coronary intervention), cardiomyopathy, myocarditis, pulmonary embolism, refractory ventricular tachycardia, shock during coronary intervention.
  • Those voluntarily consenting to the medical records and the data necessary for the study during the entire study period.

排除标准

  • Other causes except for cardiogenic shock (low blood pressure, septic, obstructive shock)
  • Shock with cardiac arrest outside the hospital
  • People with allergic reactions to anticoagulants such as heparin.
  • Those who refused active treatment.

结局指标

主要结局

In hospital death

时间窗: for 1 year

次要结局

  • Death in 28days(28days)
  • Death in 1 year(1 year)
  • hospitalization days(1 year)
  • Successful removal of left ventricular assist device (IABP, ECMO)(1 year)
  • Death, myocardial infarction, stroke, re-admission due to heart failure during follow-up.(1 year)
  • Lactate 24 hour clearance(1 year)
  • Number of days of intensive care unit Number of days of intensive care unit(1 year)

研究者

发起方
Jeong Hoon Yang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jeong Hoon Yang

Professor

Samsung Medical Center

研究点 (1)

Loading locations...

相似试验